Date Initiated by Firm |
July 07, 2008 |
Date Posted |
September 16, 2008 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number |
Z-2297-2008 |
Recall Event ID |
48714 |
Product Classification |
Patient Helper Reinforced Overhead Bar - Product Code IKX
|
Product |
Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc., Warsaw, The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed. IN; Prod. Nos. 00-2700-965-02 and 00-0965-001-00. |
Code Information |
All units shipped between 7/11/07 and 5/19/08. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact |
800-321-5533
|
Manufacturer Reason for Recall |
If the bed is in the upright position and the bar is dropped rapidly or in free-fall, it could strike the patient in the bed, and the drop could present a laceration hazard by creating a sharp edge on the metal bar.
|
FDA Determined Cause 2 |
Device Design |
Action |
Consignees were notified via recall letter dated 7/7/08 to discontinue use of these devices until the firm visits and replaces the devices. Contact Zimmer at 1-800-321-5533 for assistance. |
Quantity in Commerce |
645 of all systems |
Distribution |
Nationwide and Canada. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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